Recall Notice: damaged Curlin infusion pumps can lead to over delivery - For Health Professionals

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Contact: Marketed Health Products Directorate (MHPD)

Health Canada Endorsed Important Safety Information on Curlin Infusion Pumps

June 23, 2008

Subject: Recall Notice: Damaged Curlin Infusion Pumps: Can lead to over delivery.

PRODUCT AFFECTED:

Model Number	Model Name
340-1001	Model 2000 CMS/ Model 2000 Plus Ambulatory Infusion Pump
350-1001	Model 4000 Plus Ambulatory Infusion Pump
350-1101	Model 4000 CMS Ambulatory Infusion Pump
360-1101	Model 6000 CMS, IOD, or Plus Ambulatory Infusion Pump
360-1301	PainSmart, PainSmart IOD Ambulatory Infusion System

LOT/SERIAL NUMBERS: All

REASON FOR NOTICE

In the United States and Canada, Curlin Medical has investigated five cases of over-delivery or free-flow in the past eight months involving Curlin ambulatory peristaltic multi-therapy infusion pumps where the pumping chamber door (platen) had become damaged in a manner that permitted gravity flow. Our investigations have identified the damage to have been a result of physical impact of the product, i.e. the pump being dropped with the door (platen) in the open position.

This recall action is designed to highlight to users and caregivers the need to have infusion pumps that have been subjected to physical impact, like being dropped, tested prior to continued use. We also recommend a performance check protocol in between patient for both inpatient and outpatient care settings.

ACTIONS REQUIRED

Functional Test
All users are encouraged to perform a functional test. The new procedures replace the "Volumetric Delivery Test" procedures in the identified user manuals and can be found on the Curlin Medical, Inc. Website. It is important that the user Manual Addendums is followed.

Devices Failing Functional Test
All pumps that fail the functional test must be returned to Curlin Medical for investigation and repair. Please call Curlin Medical Customer Service at 888-287-5999 for return instructions. Returned pumps will be repaired and returned. A service/loaner pump will be provided at your request, while your pump is being repaired.

Devices Passing Functional Test
To enhance safety and as a reminder that damage may occur if a pump is dropped during use, a Warning Label is to be affixed to the pump.

Further Information

For further information, questions, or concerns please contact Curlin Medical Customer Service at 888-287-5999.

We also encourage you to report adverse events related to over-infusion or free-flow to Curlin Medical and to the Health Products and Food Branch Inspectorate of Health Canada.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents in patients treated with Curlin Infusion Pumps should be reported to Curlin Medical or to Health Canada at the following address:

Sincerely,

original signed by

Micheal L. Henderson
Group Director, Quality & Regulatory Affairs
Medical Device Group
Moog, Inc.